GMP Maintenance Technician II (DPI)/ Senior GMP Maintenance Technician (DPI)

United Therapeutics Corporation; Durham (NC); On-site; USD 80,000 - 105,000; Full time

Job summary

United Therapeutics Corporation is seeking a GMP Maintenance Technician II (DPI) or Senior GMP Maintenance Technician (DPI) to perform planned and unplanned maintenance on manufacturing lines for Tyvaso DPI. The role requires strong troubleshooting, CMMS documentation, and collaboration with vendors and internal teams.

On-site at Durham, NC, with potential site travel for DPI manufacturing and kitting equipment support; candidates should have 4+ years (II) or 6+ years (Senior) in pharma/biotech

Qualifications

• HS Diploma or GED required.
• 4+ years of maintenance experience in pharma/biotech/manufacturing environment.
• Experience troubleshooting pneumatic, electrical and hydraulic control systems.
• Proficient in use of test equipment (digital voltmeters, temperature probes, pneumatic calibrators).
• Strong communication and multi-tasking skills.

Responsibilities

• Perform preventative and corrective maintenance on GMP manufacturing lines to ensure uptime.
• Troubleshoot and repair mechanical, electrical, and automation systems with limited supervision.
• Maintain CMMS records and spare parts inventory.
• Support quality events, deviations, CAPAs, and change controls as needed.

Skills

Pneumatic control

Electrical control

Hydraulic control

Troubleshooting

Communication

Education

GED/High School Diploma

Associate Degree in mechanical or technical studies

Tools

Digital voltmeters

Temperature probes

Pneumatic calibrators

Job description

## GMP Maintenance Technician II (DPI)/ Senior GMP Maintenance Technician (DPI)Applyremote type: On-Sitelocations: RTP, NCtime type: Full timeposted on: Posted 2 Days Agojob requisition id: R05131**The Job Details are as follows:**GMP Maintenance Technician II (DPI)/ Senior GMP Maintenance Technician (DPI)Who We AreWe are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You AreThe GMP Maintenance Technician II (DPI) executes planned and unplanned routine maintenance and repairs on manufacturing, filling, assembly and packing/kitting lines to ensure the efficient production and supply of Tyvaso DPI medicine. This role works closely with Mechanics team members to ensure (a) timely completion of maintenance events, (b) documentation of events progressed utilizing a Computerized Maintenance Management System (CMMS) and (c) maintenance of an accurate spare parts inventory. They will assist in identifying areas of improvement in the set-up and maintenance of cGMP equipment, and provide operational support for validation and other projects.* Assist with equipment operations and work with stakeholders and vendors to anticipate and resolve mechanical and automated equipment issues while adhering to cGMPs. This includes understanding the role equipment and systems play in meeting CPPs (certificate of pharmaceutical product) and other regulatory guidelines in DPI manufacturing and kitting operations.* Perform preventative maintenance on equipment and update BMRAM to maintain accurate records with limited supervision* Troubleshoot and diagnose mechanical, electrical, and operational issues on production equipment, applying technical judgment to resolve non-routine issues and ensuring problems are addressed quickly and effectively* Maintain proficiency with all responsibilities related to GMP Maintenance activities and apply working knowledge to improve equipment performance and reliability* Assist with obtaining maintenance proposals, approval of purchase orders, and procurement of spare parts inventory from external vendors that are needed to support DPI manufacturing and kitting equipment* Coordinate with external vendors during site visits to perform maintenance related activities on production equipment* Provide support on quality events/deviations, change controls, CAPAs and action items in TrackWise related to DPI manufacturing and kitting, including investigation support and follow-up actions* Provide support in the completion of validations and special projects, audits, and other requirements, contributing to execution and documentation. This may include some travel to other UT or vendor sites.* Perform other duties as assignedMinimum Requirements (GMP Maintenance Technician II (DPI))* H.S. Diploma or General Education Degree (GED)* Minimum 4 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment* Proficient in all Microsoft Office applications* Experience in troubleshooting and repair of pneumatic, electronic and hydraulic control systems, including diagnosing non-routine issues* Demonstrated working knowledge in the use of test equipment such as digital voltmeters, temperature probes and pneumatic calibrators* Customer focused, with ability to multi-task and maintain a high quality of work* Strong organization and problem-solving skills* Proficient written and verbal communication skills with the ability to communicate effectively across functions and with external vendors* Ability to provide guidance or technical support to less experienced techniciansPreferred Qualifications* Associate Degree in mechanical or technical vocational studies* Experience with automation systems and platforms* Advanced ability to troubleshoot and operate complex automation systems and resolve non-routine issues* Experience using a regulated database such as BMRAM or Cal ManMinimum Requirements (Senior GMP Maintenance Technician (DPI)* H.S. Diploma or General Education Degree (GED)* Minimum 6 years of experience as maintenance personnel in an industrial, pharma/biotech, or manufacturing environment* Proficient in all Microsoft Office applications* Experience with automation systems and platforms* Experience in troubleshooting and repair of pneumatic, electronic and hydraulic control systems* Ability to work well independently with minimal supervision as well as in a heavily team-focused environment* Ability to troubleshoot and operate complex automation systems* Demonstrated working knowledge in the use of test equipment such as digital voltmeters, temperature probes and pneumatic calibrators* Customer focused, with ability to multi-task and maintain a high quality of work* Experience using a regulated database such as BMRAM or Cal Man* Strong organization and problem-solving skills* Proficient written and verbal communication skills with the ability to communicate effectively across all levels and functions of businessPreferred Qualifications* Associate Degree in life science, mechanical, or technical vocational studies in related field* 4+ years of experience in the pharmaceutical/medical devices industryLocationUnited Therapeutics requires this candidate to be 100% on-site at our Durham, NC office.